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临床试验/NCT04406051
NCT04406051已完成不适用

Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. Does Time and Type of Administered Fluids Matter?

Aretaieion University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
incidence of hypotension

研究概览

简要总结

This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section

详细描述

Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading.

The aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •adult parturients, American Society of Anesthesiologists (ASA) I-II,
  • •singleton gestation>37 weeks
  • •elective cesarean section

排除标准

  • •Body Mass Index (BMI) >40 kg/m2
  • •Body weight <50 kg
  • •Body weight>100 kg
  • •height<150 cm
  • •height>180 cm
  • •multiple gestation
  • •fetal abnormality
  • •fetal distress
  • •active labor
  • •cardiac disease
  • •pregnancy-induced hypertension
  • •thrombocytopenia
  • •coagulation abnormalities
  • •use of antihypertensive medication during pregnancy
  • •communication or language barriers
  • •lack of informed consent
  • •contraindication for regional anesthesia

研究组 & 干预措施

norepinephrine infusion and colloid preloading (NOR-COL)

Active Comparator

in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive colloid preloading (5 mL/kg)

干预措施: norepinephrine infusion and colloid preloading (NOR-COL) (Procedure)

norepinephrine infusion and crystalloid co-loading (NOR-CRYS)

Active Comparator

in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive crystalloid co-loading (10 mL/kg)

干预措施: norepinephrine infusion and crystalloid co-loading (NOR-CRYST) (Procedure)

结局指标

主要结局

incidence of hypotension

时间窗: intraoperative

any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded

次要结局

  • neonatal blood gases(1 min post delivery)
  • need for vasoconstrictor(intraoperative)
  • type of vasoconstrictor administered(intraoperative)
  • total dose of vasoconstrictor administered(intraoperative)
  • incidence of bradycardia(intraoperative)
  • need for atropine(intraoperative)
  • modification or cessation of the infusion(intraoperative)
  • incidence of nausea/vomiting(intraoperative)
  • Neonatal Apgar score at 1 min(1 min post delivery)
  • Neonatal Apgar score at 5 min(5 min post delivery)
  • glucose in neonatal blood(1 min post delivery)
  • incidence of hypertension(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Kassiani Theodoraki

Professor of Anesthesiology

Aretaieion University Hospital

研究点 (2)

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